Bioterrorism: The Centers for Disease Control and Prevention's	 
Role in Public Health Protection (15-NOV-01, GAO-02-235T).	 
								 
Federal research and preparedness activities related to 	 
bioterrorism center on detecting of such agents; developing new  
or improved vaccines, antibiotics, and antivirals; and developing
performance standards for emergency response equipment. 	 
Preparedness activities include: (1) increasing federal, state,  
and local response capabilities: (2) developing response teams;  
(3) increasing the availability of medical treatments; (4)	 
participating in and sponsoring exercises; (5) aiding victims;	 
and (6) providing support at special events, such as presidential
inaugurations and Olympic games. To coordinate their activities  
to combat terrorism, federal departments and agencies are	 
developing interagency response plans, participating in various  
interagency work groups, and entering into formal agreements with
other agencies to share resources and capabilities. However,	 
coordination of federal terrorism research, preparedness, and	 
response programs is fragmented, raising concerns about the	 
ability of states and localities to respond to a bioterrorist	 
attack. These concerns include insufficient state and local	 
planning and a lack of hospital participation in training on	 
terrorism and emergency response planning.Federal research and	 
preparedness activities related to bioterrorism center on	 
detecting of such agents; developing new or improved vaccines,	 
antibiotics, and antivirals; and developing performance standards
for emergency response equipment. Preparedness activities	 
include: (1) increasing federal, state, and local response	 
capabilities: (2) developing response teams; (3) increasing the  
availability of medical treatments; (4)  participating in and	 
sponsoring exercises; (5) aiding victims; and (6) providing	 
support at special events, such as presidential inaugurations and
Olympic games. To coordinate their activities to combat 	 
terrorism, federal departments and agencies are developing	 
interagency response plans, participating in various interagency 
work groups, and entering into formal agreements with other	 
agencies to share resources and capabilities. However,		 
coordination of federal terrorism research, preparedness, and	 
response programs is fragmented, raising concerns about the	 
ability of states and localities to respond to a bioterrorist	 
attack. These concerns include insufficient state and local	 
planning and a lack of hospital participation in training on	 
terrorism and emergency response planning.Federal research and	 
preparedness activities related to bioterrorism center on	 
detecting of such agents; developing new or improved vaccines,	 
antibiotics, and antivirals; and developing performance standards
for emergency response equipment. Preparedness activities	 
include: (1) increasing federal, state, and local response	 
capabilities: (2) developing response teams; (3) increasing the  
availability of medical treatments; (4)  participating in and	 
sponsoring exercises; (5) aiding victims; and (6) providing	 
support at special events, such as presidential inaugurations and
Olympic games. To coordinate their activities to combat 	 
terrorism, federal departments and agencies are developing	 
interagency response plans, participating in various interagency 
work groups, and entering into formal agreements with other	 
agencies to share resources and capabilities. However,		 
coordination of federal terrorism research, preparedness, and	 
response programs is fragmented, raising concerns about the	 
ability of states and localities to respond to a bioterrorist	 
attack. These concerns include insufficient state and local	 
planning and a lack of hospital participation in training on	 
terrorism and emergency response planning. This testimony	 
summarizes a September 2001 report (GAO-01-915).		 
-------------------------Indexing Terms------------------------- 
REPORTNUM:   GAO-02-235T					        
    ACCNO:   A02464						        
  TITLE:     Bioterrorism: The Centers for Disease Control and	      
Prevention's Role in Public Health Protection			 
     DATE:   11/15/2001 
  SUBJECT:   Biological warfare 				 
	     Emergency preparedness				 
	     Health care services				 
	     Health hazards					 
	     Public Health Service facilities			 
	     Terrorism						 

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GAO-02-235T
     
Testimony Before the Committee on Energy and Commerce, House of
Representatives

United States General Accounting Office

GAO For Release on Delivery Expected at 10: 00 a. m. Thursday, November 15,
2001 BIOTERRORISM

The Centers for Disease Control and Prevention's Role in Public Health
Protection

Statement for the Record by Janet Heinrich Director, Health Care- Public
Health Issues

GAO- 02- 235T

Page 1 GAO- 02- 235T

Mr. Chairman and Members of the Committee: I appreciate the opportunity to
submit this statement for the record discussing our work on the Centers for
Disease Control and Prevention?s (CDC) activities to prepare the nation to
respond to the public health and medical consequences of a bioterrorist
attack. 1 The country is now dealing with anthrax exposures resulting from
the agent being sent through the mail and the consequences of dealing with
even limited exposures have proven to be quite significant. Prior to the
recent anthrax incidents, a domestic bioterrorist attack had been considered
to be a low- probability event, in part because of the various difficulties
involved in successfully delivering biological agents to achieve large-
scale casualties. 2

On September 28, 2001, we released a report 3 that describes (1) the
research and preparedness activities being undertaken by federal departments
and agencies to manage the consequences of a bioterrorist attack, (2) the
coordination of these activities, and (3) the findings of reports on the
preparedness of state and local jurisdictions to respond to a bioterrorist
attack. This statement will summarize our findings in the September report
regarding CDC?s research and preparedness activities on bioterrorism and
augments our previous work on combating terrorism. 4 Specifically, we will
focus on CDC?s research and preparedness activities on bioterrorism, and
remaining gaps that could hamper the response to a bioterrorist event.

1 Bioterrorism is the threat or intentional release of biological agents
(viruses, bacteria, or their toxins) for the purposes of influencing the
conduct of government or intimidating or coercing a civilian population.

2 See Combating Terrorism: Need for Comprehensive Threat and Risk
Assessments of Chemical and Biological Attacks (GAO/ NSIAD- 99- 163, Sept.
14, 1999), pp. 10- 15, for a discussion of the level of difficulty a
terrorist would face in attempting to cause mass casualties by making or
using chemical or biological agents without the assistance of a state-
sponsored program.

3 See Bioterrorism: Federal Research and Preparedness Activities (GAO- 01-
915, Sept. 28, 2001). This report was mandated by the Public Health
Improvement Act of 2000 (P. L. 106- 505, sec. 102). We conducted interviews
with and obtained information from the Departments of Agriculture, Commerce,
Defense, Energy, Health and Human Services (including CDC), Justice,
Transportation, the Treasury, and Veterans Affairs; the Environmental
Protection Agency; and the Federal Emergency Management Agency.

4 See the list of related GAO products at the end of this statement.

Page 2 GAO- 02- 235T

In summary, CDC has a variety of ongoing research and preparedness
activities related to bioterrorism. Most of CDC?s activities to counter
bioterrorism are focused on building and expanding public health
infrastructure 5 at the federal, state, and local levels. These include
funding research on anthrax and smallpox vaccines, increasing laboratory
capacity, and building a national pharmaceutical stockpile of drugs and
supplies to be used in an emergency. Since CDC?s bioterrorism program began
in 1999, funding increased 43 percent in fiscal year 2000 and an additional
12 percent in fiscal year 2001. While the percentage increases are
substantial, they reflect only a $73 million increase in overall spending
because many of the activities initially received relatively small
allocations. Gaps in CDC?s activities could hamper the response to a
bioterrorist attack. For instance, laboratories at all levels can quickly
become overwhelmed with requests for tests. In addition, there is a notable
lack of training focused on detecting and responding to bioterrorist
threats.

Although many aspects of an effective response to bioterrorism are the same
as those for any form of terrorism, there are some unique features. For
example, if a biological agent is released covertly, it may not be
recognized for a week or more because symptoms may not appear for several
days after the initial exposure and may be misdiagnosed at first. In
addition, some biological agents, such as smallpox, are communicable and can
spread to others who were not initially exposed. These characteristics
require responses that are unique to bioterrorism, including health
surveillance, 6 epidemiologic investigation, 7 laboratory identification of
biological agents, and distribution of antibiotics to large segments of the
population to prevent the spread of an infectious disease. However, some
aspects of an effective response to bioterrorism are also important in
responding to any type of large- scale disaster, such as providing emergency
medical services, continuing health care services delivery, and,
potentially, managing mass fatalities.

5 The public health infrastructure is the underlying foundation that
supports the planning, delivery, and evaluation of public health activities
and practices. 6 Health surveillance systems provide for the ongoing
collection, analysis, and dissemination of data to prevent and control
disease. 7 Epidemiological investigation is the study of patterns of health
or disease and the factors that influence these patterns. Background

Page 3 GAO- 02- 235T

The burden of responding to bioterrorist incidents falls initially on
personnel in state and local emergency response agencies. These ?first

responders? include firefighters, emergency medical service personnel, law
enforcement officers, public health officials, health care workers
(including doctors, nurses, and other medical professionals), and public
works personnel. If the emergency requires federal disaster assistance,
federal departments and agencies will respond according to responsibilities
outlined in the Federal Response Plan. 8

Under the Federal Response Plan, CDC is the lead Department of Health and
Human Services (HHS) agency providing assistance to state and local
governments for five functions: (1) health surveillance, (2) worker health
and safety, (3) radiological, chemical, and biological hazard consultation,
(4) public health information, and (5) vector control. 9 Each of these
functions is described in table 1.

8 The Federal Response Plan, originally drafted in 1992 and updated in 1999,
is authorized under the Robert T. Stafford Disaster Relief and Emergency
Assistance Act (Stafford Act; P. L. 93- 288, as amended). The plan outlines
the planning assumptions, policies, concept of operations, organizational
structures, and specific assignment of responsibilities to lead departments
and agencies in providing federal assistance once the President has declared
an emergency requiring federal assistance.

9 A vector is a carrier, such as an insect, that transmits the organisms of
disease from infected to noninfected individuals.

Page 4 GAO- 02- 235T

Table 1: CDC?s Functions Under the Federal Response Plan Function
Description of function

Health surveillance Assist in establishing surveillance systems to monitor
the general population and special high- risk population segments; carry out
field studies and investigations; monitor injury and disease patterns and
potential disease outbreaks; and provide technical assistance and
consultations on disease and injury prevention and precautions. Worker
health and safety Assist in monitoring health and well- being of emergency
workers; perform field investigations and

studies; and provide technical assistance and consultation on worker health
and safety measures and precautions. Radiological, chemical, and biological
hazard consultation

Assist in assessing health and medical effects of radiological, chemical,
and biological exposures on the general population and on high- risk
population groups; conduct field investigations, including collection and
analysis of relevant samples; advise on protective actions related to direct
human and animal exposure, and on indirect exposure through radiologically,
chemically, or biologically contaminated food, drugs, water supply, and
other media; and provide technical assistance and consultation on medical
treatment and decontamination of radiologically, chemically, or biologically
injured or contaminated victims. Public health information Assist by
providing public health and disease and injury prevention information that
can be transmitted

to members of the general public who are located in or near areas affected
by a major disaster or emergency. Vector control Assist in assessing the
threat of vector- borne diseases following a major disaster or emergency;

conduct field investigations, including the collection and laboratory
analysis of relevant samples; provide vector control equipment and supplies;
provide technical assistance and consultation on protective actions
regarding vector- borne diseases; and provide technical assistance and
consultation on medical treatment of victims of vector- borne diseases.

Source: The Health and Medical Services Annex in the Federal Response Plan,
April 1999.

HHS is currently leading an effort to work with governmental and
nongovernmental partners to upgrade the nation?s public health
infrastructure and capacities to respond to bioterrorism. 10 As part of this
effort, several CDC centers, institutes, and offices work together in the
agency?s Bioterrorism Preparedness and Response Program. The principal
priority of CDC?s program is to upgrade infrastructure and capacity to
respond to a large- scale epidemic, regardless of whether it is the result
of a bioterrorist attack or a naturally occurring infectious disease
outbreak. The program was started in fiscal year 1999 and was tasked with
building and enhancing national, state, and local capacity; developing a
national pharmaceutical stockpile; and conducting several independent
studies on bioterrorism.

10 Beyond CDC, other offices and agencies within HHS are involved in this
effort, including the Agency for Healthcare Research and Quality, the Food
and Drug Administration, the National Institutes of Health, and the Office
of Emergency Preparedness.

Page 5 GAO- 02- 235T

CDC is conducting a variety of activities related to research on and
preparedness for a bioterrorist attack. Since CDC?s program began 3 years
ago, funding for these activities has increased. Research activities focus
on detection, treatment, vaccination, and emergency response equipment.
Preparedness efforts include increasing state and local response capacity,
increasing CDC?s response capacity, preparedness and response planning, and
building the National Pharmaceutical Stockpile Program.

The funding for CDC?s activities related to research on and preparedness for
a bioterrorist attack has increased 61 percent over the past 2 years. See
table 2 for reported funding for these activities.

Table 2: Reported Funding for CDC?s Bioterrorism Preparedness and Response
Program Activities (Dollars in millions)

Program/ initiative a Fiscal year 1999 Fiscal year

2000 Fiscal year

2001 Research activities

Research and development 0 $40.5 $42.9 Independent studies b $1.8 $7.7 $2.6
Worker safety 0 0 $1.1

Preparedness activities Upgrading state and local capacity $55.0 $56.9 $66.7

Preparedness planning $2.0 $1.9 $5.8 Surveillance and epidemiology $12.0
$15.8 $16.1 Laboratory capacity $13.0 $9.5 $12.8 Communications $28.0 $29.7
$32.0

Upgrading CDC capacity $12.0 $13.9 $20.4

Epidemiologic capacity $2.0 $1.8 $4.0 Laboratory capacity $5.0 $7.6 $11.4
Rapid toxic screening $5.0 $4.5 $5.0

Preparedness and response planning $1.0 $2.3 $9.2 Building the National
Pharmaceutical Stockpile Program $51.0 $51.8 $51.0 Total $120.8 $173.1
$193.9

Note: We have not audited or otherwise verified the information provided. a
CDC also received funding in fiscal year 1999, fiscal year 2000, and fiscal
year 2001 for bioterrorism

deterrence activities, such as implementing regulations restricting the
importation of certain biological agents. That funding is not included here.
b For instance, $1 million was specified in the fiscal year 2000
appropriations conference report for the

Carnegie Mellon Research Institute to study health and bioterrorism threats.
Source: CDC.

CDC?s Research and Preparedness Activities on Bioterrorism

Trends in CDC?s Funding for Bioterrorism Activities

Page 6 GAO- 02- 235T

Funding for CDC?s Bioterrorism Preparedness and Response Program grew
approximately 43 percent in fiscal year 2000 and an additional 12 percent in
fiscal year 2001. While the percentage increases are significant, they
reflect only a $73 million increase because many of the programs initially
received relatively small allocations. Approximately $45 million of the
overall two- year increase was due to new research activities.

Relative changes in funding for the various components of CDC?s Bioterrorism
Preparedness and Response Program are shown in Figure 1. Funding for
research activities increased sharply from fiscal year 1999 to fiscal year
2000, and then dropped slightly in fiscal year 2001. The increase in fiscal
year 2000 was largely due to a $40. 5 million increase in research funding
for studies on anthrax and smallpox. Funding for preparedness and response
planning, upgrading CDC capacity, and upgrading state and local capacity was
relatively constant between fiscal year 1999 and fiscal year 2000 and grew
in fiscal year 2001. For example, funding increased to upgrade CDC capacity
by 47 percent and to upgrade state and local capacity by 17 percent in
fiscal year 2001. The National Pharmaceutical Stockpile Program experienced
a slight increase in funding of 2 percent in fiscal year 2000 and a slight
decrease in funding of 2 percent in fiscal year 2001.

Page 7 GAO- 02- 235T

Figure 1: CDC?s Bioterrorism Preparedness and Response Program Funding

Source: GAO analysis of CDC data.

CDC?s research activities focus on detection, treatment, vaccination, and
emergency response equipment. In fiscal year 2001, CDC was allocated $18
million to continue research on an anthrax vaccine and associated issues,
such as scheduling and dosage. The agency also received $22.4 million in
fiscal year 2001 to conduct smallpox research. In addition, CDC oversees a
number of independent studies, which fund specific universities and
hospitals to do research and other work on bioterrorism. For example,
funding in fiscal year 2001 included $941,000 to the University of Findlay
in Findlay, Ohio, to develop training for health care providers and other
Research Activities

0 10

20 30

40 50

60 70

1999 2000 2001 Fiscal Year

Preparedness and Response Planning Upgrading State and Local Capacity

Upgrading CDC Capacity National Pharmaceutical Stockpile Program Research
Activities

Dollars in millions

Page 8 GAO- 02- 235T

hospital staff on how to handle victims who come to an emergency department
during a bioterrorist incident. Another $750,000 was provided to the
University of Texas Medical Branch in Galveston, Texas, to study various
viruses in order to discover means to prevent or treat infections by these
and other viruses (such as Rift Valley Fever and the smallpox virus). For
worker safety, CDC?s National Institute for Occupational Safety and Health
is developing standards for respiratory protection equipment used against
biological agents by firefighters, laboratory technicians, and other
potentially affected workers.

Most of CDC?s activities to counter bioterrorism are focused on building and
expanding public health infrastructure at the federal, state, and local
levels. For example, CDC reported receiving funding to upgrade state and
local capacity to detect and respond to a bioterrorist attack. CDC received
additional funding for upgrading its own capacity in these areas, for
preparedness and response planning, and for developing the National
Pharmaceutical Stockpile Program. In addition to preparing for a
bioterrorist attack, these activities also prepare the agency to respond to
other challenges, such as identifying and containing a naturally occurring
emerging infectious disease.

CDC provides grants, technical support, and performance standards to support
bioterrorism preparedness and response planning at the state and local
levels. In fiscal year 2000, CDC funded 50 states and four major
metropolitan health departments for preparedness and response activities.
CDC is developing planning guidance for state public health officials to
upgrade state and local public health departments? preparedness and response
capabilities. In addition, CDC has worked with the Department of Justice to
complete a public health assessment tool, which is being used to determine
the ability of state and local public health agencies to respond to release
of biological and chemical agents, as well as other public health
emergencies. Ten states (Florida, Hawaii, Maine, Michigan, Minnesota,
Pennsylvania, Rhode Island, South Carolina, Utah, and Wisconsin) have
completed the assessment, and others are currently completing it.

States have received funding from CDC to increase staff, enhance capacity to
detect the release of a biological agent or an emerging infectious disease,
and improve communications infrastructure. In fiscal year 1999, for example,
a total of $7.8 million was awarded to 41 state and local health agencies to
improve their ability to link different sources of data, Preparedness
Activities

Upgrading State and Local Capacity

Page 9 GAO- 02- 235T

such as sales of certain pharmaceuticals, which could be helpful in
detecting a covert bioterrorist event.

Rapid identification and confirmatory diagnosis of biological agents are
critical to ensuring that prevention and treatment measures can be
implemented quickly. CDC was allocated $13 million in fiscal year 1999 to
enhance state and local laboratory capacity. CDC has established a
Laboratory Response Network of federal, state, and local laboratories that
maintain state- of- the- art capabilities for biological agent
identification and characterization of human clinical samples such as blood.
CDC has provided technical assistance and training in identification
techniques to state and local public health laboratories. In addition, five
state health departments received awards totaling $3 million to enhance
chemical laboratory capabilities from the fiscal year 2000 funds. The states
used these funds to purchase equipment and provide training.

CDC is working with state and local health agencies to improve electronic
infrastructure for public health communications for the collection and
transmission of information related to a bioterrorism incident as well as
other events. For example, $21 million was awarded to states in fiscal year
1999 to begin implementation of the Health Alert Network, which will support
the exchange of key information over the Internet and provide a means to
conduct distance training that could potentially reach a large segment of
the public health community. Currently, 13 states are connected to all of
their local jurisdictions. CDC is also directly connected to groups such as
the American Medical Association to reach healthcare providers.

CDC has described the Health Alert Network as a ?highway? on which programs,
such as the National Electronic Disease Surveillance System (NEDSS) and the
Epidemic Information Exchange (Epi- X), will run. NEDSS is designed to
facilitate the development of an integrated, coherent national system for
public health surveillance. Ultimately, it is meant to support the automated
collection, transmission, and monitoring of disease data from multiple
sources (for example, clinician?s offices and laboratories) from local to
state health departments to CDC. This year, a total of $10.9 million will go
to 36 jurisdictions for new or continuing NEDSS activities. Epi- X is a
secure, Web- based exchange for public health officials to rapidly report
and discuss disease outbreaks and other health events potentially related to
bioterrorism as they are identified and investigated.

Page 10 GAO- 02- 235T

CDC is upgrading its own epidemiologic and disease surveillance capacity. It
has deployed, and is continuing to enhance, a surveillance system to
increase surveillance and epidemiological capacities before, during, and
after special events (such as the 1999 World Trade Organization meeting in
Seattle). Besides improving emergency response at the special events, the
agency gains valuable experience in developing and practicing plans to
combat terrorism. In addition, CDC monitors unusual clusters of illnesses,
such as influenza in June. Although unusual clusters are not always a cause
for concern, they can indicate a potential problem. The agency is also
increasing its surveillance of disease outbreaks in animals.

CDC has strengthened its own laboratory capacity. For example, it is
developing and validating new diagnostic tests as well as creating
agentspecific detection protocols. In collaboration with the Association of
Public Health Laboratories and the Department of Defense, CDC has started a
secure Web- based network that allows state, local, and other public health
laboratories access to guidelines for analyzing biological agents. The site
also allows authenticated users to order critical reagents 11 needed in
performing laboratory analysis of samples.

The agency has also opened a Rapid Response and Advance Technology
Laboratory, which screens samples for the presence of suspicious biological
agents and evaluates new technology and protocols for the detection of
biological agents. These technology assessments and protocols, as well as
reagents and reference samples, are being shared with state and local public
health laboratories.

One activity CDC has undertaken is the implementation of a national
bioterrorism response training plan. This plan focuses on preparing CDC
officials to respond to bioterrorism and includes the development of
exercises to assess progress in achieving bioterrorism preparedness at the
federal, state, and local levels. The agency is also developing a crisis
communications/ media response curriculum for bioterrorism, as well as core
capabilities guidelines to assist states and localities in their efforts to
build comprehensive anti- bioterrorism programs.

CDC has developed a bioterrorism information Web site. This site provides
emergency contact information for state and local officials in the event of
possible bioterrorism incidents, a list of critical biological and chemical

11 A reagent is a substance used to detect the presence of another
substance. Upgrading CDC Capacity

Preparedness and Response Planning

Page 11 GAO- 02- 235T

agents, summaries of state and local bioterrorism projects, general
information about CDC?s bioterrorism initiative, and links to documents on
bioterrorism preparedness and response.

The National Pharmaceutical Stockpile Program maintains a repository of
life- saving pharmaceuticals, antidotes, and medical supplies, known as
12Hour Push Packages, that could be used in an emergency, including a
bioterrorist attack. The packages can be delivered to the site of a
biological (or chemical) attack within 12 hours of deployment for the
treatment of civilians. The first emergency use of the National
Pharmaceutical Stockpile occurred on September 11, 2001, when in response to
the terrorist attack on the World Trade Center, CDC released one of the
eight Push Packages.

The National Pharmaceutical Stockpile also includes additional antibiotics,
antidotes, other drugs, medical equipment, and supplies, known as the Vendor
Managed Inventory, that can be delivered within 24 to 36 hours after the
appropriate vendors are notified. Deliveries from the Vendor Managed
Inventory can be tailored to an individual incident. The program received
$51.0 million in fiscal year 1999, $51.8 million in fiscal year 2000, and
$51.0 million in fiscal year 2001. CDC and the Office of Emergency
Preparedness (another agency in HHS that also maintains a stockpile of
medical supplies) have encouraged state and local representatives to
consider stockpile assets in their emergency planning for a biological
attack and have trained representatives from state and local authorities in
using the stockpile. The stockpile program also provides technical advisers
in response to an event to ensure the appropriate and timely transfer of
stockpile contents to authorized state representatives. 12 Recently,
individuals who may have been exposed to anthrax through the mail have been
given antibiotics from the Vendor Managed Inventory.

12 For more information on the National Pharmaceutical Stockpile Program,
see Combating Terrorism: Accountability Over Medical Supplies Needs Further
Improvement

(GAO- 01- 463, Mar. 30, 2001). Building the National

Pharmaceutical Stockpile Program

Page 12 GAO- 02- 235T

While CDC has funded research and preparedness programs for bioterrorism, a
great deal of work remains to be done. CDC and HHS have identified gaps in
bioterrorism research and preparedness that need to be addressed. In
addition, some of our work on naturally occurring diseases also also
indicates gaps in preparedness that would be important in the event of a
bioterrorist attack.

Gaps in research activities center on vaccines and field testing for
infectious agents. CDC has reported that it needs to continue the smallpox
vaccine development and production contract begun in fiscal year 2000. This
includes clinical testing of the vaccine and submitting a licensing
application to the Food and Drug Administration for the prevention of
smallpox in adults and children. 13 CDC also plans to conduct further
studies of the anthrax vaccine. This research will include studies to better
understand the immunological response that correlates with protection
against inhalation anthrax and risk factors for adverse events as well as
investigating modified vaccination schedules that could maintain protection
and result in fewer adverse reactions. The agency has also indicated that it
needs to continue research in the area of rapid assay tests to allow field
diagnosis of a biological or chemical agent.

Gaps remain in all of the areas of preparedness activities under CDC?s
program. In particular, there are many unmet needs in upgrading state and
local capacity to respond to a bioterrorist attack. There are also further
needs in upgrading CDC?s capacity, preparedness and response planning, and
building the National Pharmaceutical Stockpile.

Health officials at many levels have called for CDC to support bioterrorism
planning efforts at the state and local level. In a series of regional
meetings from May through September 2000 to discuss issues associated with
developing comprehensive bioterrorism response plans, state and local
officials identified a need for additional federal support of their planning
efforts. This includes federal efforts to develop effective written planning

13 Previous plans were for 40 million doses of the vaccine to be produced
initially, with expected delivery of the first full- scale production lots
in 2004. The department now plans to expand and accelerate production
significantly. Gaps in CDC?s

Research and Preparedness Activities for Bioterrorism

Research Activities Preparedness Activities Upgrading State and Local
Capacity

Page 13 GAO- 02- 235T

guidance for state and local health agencies and to provide on- site
assistance that will ensure optimal preparedness and response.

HHS has noted that surveillance capabilities need to be increased. In
addition to enhancing traditional state and local capabilities for
infectious disease surveillance, HHS has recognized the need to expand
surveillance beyond the boundaries of the public health departments. In the
department?s FY 2002- FY 2006 Plan for Combating Bioterrorism, HHS notes
that potential sources for data on morbidity trends include 911 emergency
calls, reasons for emergency department visits, hospital bed usage, and the
purchase of specific products at pharmacies. Improved monitoring of food is
also necessary to reduce its vulnerability as an avenue of infection and of
terrorism. Other sources beyond public health departments can provide
critical information for detection and identification of an outbreak. For
example, the 1999 West Nile virus outbreak showed the importance of links
with veterinary surveillance. 14 Initially there were two separate
investigations: one of sick people, the other of dying birds. Once the two
investigations converged, the link was made, and the virus was correctly
identified.

HHS has found that state and local laboratories need to continue to upgrade
their facilities and equipment. The department has stated that it would be
beneficial if research, hospital, and commercial laboratories that have
state- of- the- art equipment and well- trained staff were added to the
National Laboratory Response Network. Currently, there are 104 laboratories
in the network that can provide testing of biological samples for detection
and confirmation of biological agents. Based on the 2000 regional meetings,
CDC concluded that it needs to continue to support the laboratory network
and identify opportunities to include more clinical laboratories to provide
additional surge capacity.

CDC also concluded from the 2000 regional meetings that, although it has
begun to develop information systems, it needs to continue to enhance these
systems to detect and respond to biological and chemical terrorism. HHS has
stated that the work that has begun on the Health Alert Network, NEDSS, and
Epi- X needs to continue. One aspect of this work is developing, testing,
and implementing standards that will permit surveillance data from different
systems to be easily shared.

14 See West Nile Virus Outbreak: Lessons for Public Health Preparedness

(GAO/ HEHS- 00- 180, Sept. 11, 2000).

Page 14 GAO- 02- 235T

During the West Nile virus outbreak, while a secure electronic communication
network was in place at the time of the initial outbreak, not all involved
agencies and officials were capable of using it at the same time. For
example, because CDC?s laboratory was not linked to the New York State
network, the New York State Department of Health had to act as an
intermediary in sharing CDC?s laboratory test results with local health
departments. CDC and the New York State Department of Health laboratory
databases were not linked to the database in New York City, and laboratory
results consequently had to be manually entered there. These problems slowed
the investigation of the outbreak.

Moreover, we have testified that there is also a notable lack of training
focused on detecting and responding to bioterrorist threats. 15 Most
physicians and nurses have never seen cases of certain diseases, such as
smallpox or plague, and some biological agents initially produce symptoms
that can be easily confused with influenza or other, less virulent
illnesses, leading to a delay in diagnosis or identification. Medical
laboratory personnel require training because they also lack experience in
identifying biological agents such as anthrax.

HHS has stated that epidemiologic capacity at CDC also needs to be improved.
A standard system of disease reporting would better enable CDC to monitor
disease, track trends, and intervene at the earliest sign of unusual or
unexplained illness.

HHS has noted that CDC needs to enhance its in- house laboratory
capabilities to deal with likely terrorist agents. CDC plans to develop
agent- specific detection and identification protocols for use by the
laboratory response network, a research agenda, and guidelines for
laboratory management and quality assurance. CDC also plans further
development of its Rapid Response and Advanced Technology Laboratory.

As we reported in September 2000, even the West Nile virus outbreak, which
was relatively small and occurred in an area with one of the nation?s
largest local public health agencies, taxed the federal, state, and local
laboratory resources. Both the New York State and the CDC laboratories were
quickly inundated with requests for tests during the West Nile virus
outbreak, and because of the limited capacity at the New York

15 See Bioterrorism: Review of Public Health Preparedness Programs (GAO- 02-
149T, Oct. 12, 2001). Upgrading CDC Capacity

Page 15 GAO- 02- 235T

laboratories, the CDC laboratory handled the bulk of the testing. Officials
indicated that the CDC laboratory would have been unable to respond to
another outbreak, had one occurred at the same time.

CDC plans to work with other agencies in HHS to develop guidance to
facilitate preparedness planning and associated investments by local- level
medical and public health systems. The department has stated that to the
extent that the guidance can help foster uniformity across local efforts
with respect to preparedness concepts and structural and operational
strategies, this would enable government units to work more effectively
together than if each local approach was essentially unique. More generally,
CDC has found a need to implement a national strategy for public health
preparedness for bioterrorism, and to work with federal, state, and local
partners to ensure communication and teamwork in response to a potential
bioterrorist incident.

Planning needs to continue for potential naturally occurring epidemics as
well. In October 2000, we reported that federal and state influenza pandemic
plans are in various stages of completion and do not completely or
consistently address key issues surrounding the purchase, distribution, and
administration of vaccines and antiviral drugs. 16 At the time of our
report, 10 states either had developed or were developing plans using
general guidance from CDC, and 19 more states had plans under development.
Outstanding issues remained, however, because certain key federal decisions
had not been made. For example, HHS had not determined the proportion of
vaccines and antiviral drugs to be purchased, distributed, and administered
by the public and private sectors or established priorities for which
population groups should receive vaccines and antiviral drugs first when
supplies are limited. As of July 2001, HHS continued to work on a national
plan. As a result, policies may differ among states and between states and
the federal government, and in the event of a pandemic, these
inconsistencies could contribute to public confusion and weaken the
effectiveness of the public health response.

The recent anthrax incidents have focused a great deal of attention on the
national pharmaceutical stockpile. Prior to this, in its FY2002 - FY 2006
Plan for Combating Bioterrorism, HHS had indicated what actions would be
necessary regarding the stockpile over the next several years. These

16 See Influenza Pandemic: Plan Needed for Federal and State Response (GAO-
01- 4, Oct. 27, 2000). Preparedness and Response

Planning Building the National Pharmaceutical Stockpile

Page 16 GAO- 02- 235T

included purchasing additional products so that pharmaceuticals were
available for treating additional biological agents in fiscal year 2002, and
conducting a demonstration project that incorporates the National Guard in
planning for receipt, transport, organization, distribution, and
dissemination of stockpile supplies in fiscal year 2003. CDC also proposed
providing grants to cities in fiscal year 2004 to hire a stockpile program
coordinator to help the community develop a comprehensive plan for handling
the stockpile and organizing volunteers trained to manage the stockpile
during a chemical or biological event. Clearly, these longer range plans are
changing, but the need for these activities remains.

For further information about this statement, please contact me at (202)
512- 7118. Robert Copeland, Marcia Crosse, Greg Ferrante, David Gootnick,
Deborah Miller, and Roseanne Price also made key contributions to this
statement. Contact and

Acknowledgments

Page 17 GAO- 02- 235T

Homeland Security: A Risk Management Approach Can Guide Preparedness Efforts
(GAO- 02- 208T, Oct. 31, 2001).

Terrorism Insurance: Alternative Programs for Protecting Insurance Consumers
(GAO- 02- 199T, Oct. 24, 2001).

Terrorism Insurance: Alternative Programs for Protecting Insurance Consumers
(GAO- 02- 175T, Oct. 24, 2001).

Combating Terrorism: Considerations for Investing Resources in Chemical and
Biological Preparedness (GAO- 02- 162T, Oct. 17, 2001).

Homeland Security: Need to Consider VA?s Role in Strengthening Federal
Preparedness (GAO- 02- 145T, Oct. 15, 2001).

Homeland Security: Key Elements of a Risk Management Approach

(GAO- 02- 150T, Oct. 12, 2001).

Bioterrorism: Review of Public Health Preparedness Programs (GAO- 02149T,
Oct. 10, 2001).

Bioterrorism: Public Health and Medical Preparedness (GAO- 02- 141T, Oct. 9,
2001).

Bioterrorism: Coordination and Preparedness (GAO- 02- 129T, Oct. 5, 2001).

Bioterrorism: Federal Research and Preparedness Activities (GAO- 01915,
Sept. 28, 2001).

Combating Terrorism: Selected Challenges and Related Recommendations (GAO-
01- 822, Sept. 20, 2001).

Combating Terrorism: Comments on H. R. 525 to Create a President?s Council
on Domestic Terrorism Preparedness (GAO- 01- 555T, May 9, 2001).

Combating Terrorism: Accountability Over Medical Supplies Needs Further
Improvement (GAO- 01- 666T, May 1, 2001).

Combating Terrorism: Observations on Options to Improve the Federal Response
(GAO- 01- 660T, Apr. 24, 2001). Related GAO Products

Page 18 GAO- 02- 235T

Combating Terrorism: Accountability Over Medical Supplies Needs Further
Improvement (GAO- 01- 463, Mar. 30, 2001).

Combating Terrorism: Comments on Counterterrorism Leadership and National
Strategy (GAO- 01- 556T, Mar. 27, 2001).

Combating Terrorism: FEMA Continues to Make Progress in Coordinating
Preparedness and Response (GAO- 01- 15, Mar. 20, 2001).

Combating Terrorism: Federal Response Teams Provide Varied Capabilities;
Opportunities Remain to Improve Coordination (GAO- 0114, Nov. 30, 2000).

Influenza Pandemic: Plan Needed for Federal and State Response (GAO01- 4,
Oct. 27, 2000).

West Nile Virus Outbreak: Lessons for Public Health Preparedness

(GAO/ HEHS- 00- 180, Sept. 11, 2000).

Combating Terrorism: Linking Threats to Strategies and Resources

(GAO/ T- NSIAD- 00- 218, July 26, 2000).

Chemical and Biological Defense: Observations on Nonmedical Chemical and
Biological R& D Programs (GAO/ T- NSIAD- 00- 130, Mar. 22, 2000).

Combating Terrorism: Need to Eliminate Duplicate Federal Weapons of Mass
Destruction Training (GAO/ NSIAD- 00- 64, Mar. 21, 2000).

Combating Terrorism: Chemical and Biological Medical Supplies Are Poorly
Managed (GAO/ T- HEHS/ AIMD- 00- 59, Mar. 8, 2000).

Combating Terrorism: Chemical and Biological Medical Supplies Are Poorly
Managed (GAO/ HEHS/ AIMD- 00- 36, Oct. 29, 1999).

Food Safety: Agencies Should Further Test Plans for Responding to Deliberate
Contamination (GAO/ RCED- 00- 3, Oct. 27, 1999).

(290153)
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